October 14, 2013 — The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter because aegeline, an ingredient in OxyElite Pro and VERSA-1, has not been approved for use in dietary supplements. The FDA warns that findings suggest a “causal connection” between OxyElite Pro and liver injuries reported in Hawaii.
The FDA does not normally blame products for illnesses, but they have pointed to several factors linking OxyElite Pro to dozens of cases of acute, non-viral hepatitis (liver inflammation).
Evidence linking OxyElite Pro to the illnesses includes:
- The FDA reviewed 20 medical records and found that 14 patients (70%) took OxyElite Pro before getting sick.
- The patients had nothing in common except taking OxyElite Pro.
- For eight patients, OxyElite Pro was the only supplement they were taking.
- Most of the patients were perfectly healthy before getting sick.
- Most patients recovered after stopping OxyElite Pro.
Federal law requires dietary supplement manufacturers to tell the FDA when they introduce new ingredients after October 15, 1994. The company must submit a “New Dietary Ingredient” (NDI) notification, which proves that the supplement is not chemically altered and is “reasonably expected to be safe.” The FDA has never received a notification for aegeline in OxyElite Pro or VERSA-1.
In both cases, the FDA warned USPLabs that they must stop selling the products and respond in writing within 15 days with specific steps taken to correct violations. If they do not, they could face enforcement action without further notice. Last time this happened, it took the FDA over a year to seize OxyElite Pro.
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